Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System— 510(k) K182468

Clearance details

Applicant

Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2018-09-10

Decision date

2019-03-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mahwah, NJ, US

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Death

73

Injury

31,640

Malfunction

3,358

Other

2

Total

35,073

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →